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RecruitingNCT06878482Updated Mar 17, 2025

Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease

A Phase 4 interventional study of Botulinum toxin A in Chronic Ulcer of Lower Extremity, Wound and Botulinum Toxins, Type A, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Apr 2023, registered Jan 2024).
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the effect of subcutaneous injection of botulinum toxin A on wound healing caused by lower extremity ischemia.

Read the detailed description

Tissues below the calf are governed by blood flow from the anterior tibial artery, peroneal artery, and posterior tibial artery. When an ulcer occurs due to acute lower extremity ischemia, one of the three blood vessels is blocked by a blood clot, or when the blood vessel is narrowed due to perivascular inflammation, such as Buerger's disease, it occurs in a subacute or chronic form. In particular, in the case of elderly patients with ulcers or diabetic feet due to lower extremity ischemia, the symptoms are often worsened by chronic narrowing of blood vessels due to arteriosclerosis or blockage by blood clots. To treat this, prostaglandin or antithrombotic drugs are taken, and blood flow is resumed through stent surgery, but in the lower extremities, the recurrence rate is relatively high because the blood vessels are smaller than the iliac artery, femoral artery, and popliteal artery.

Botulinum toxin is known to have a positive effect on wound healing and blood flow improvement. Botulinum toxin has been published several times in papers showing its spasmolytic effect by participating in the radiographic hip osteoarthritis Ras homolog A (RhoA)/Rock-assisted protein kinase (ROCK) pathway. In addition, botulinum toxin has a vasodilating effect related to the calcitonin gene-related peptide (CGRP) pathway, and is involved in increasing vascular endothelial growth factor (VEGF) from NO-mediated angiogenesis, inhibiting vasoconstriction, increasing blood flow rate, and promoting angiogenesis.

In this study, in patients with chronic wounds on the feet, whose lower extremity blood vessels circulate mainly through collateral circulation, subcutaneous injection of Botulinum toxin in and around the wound improves blood flow around the wound and confirms the degree of wound healing.

02

Conditions studied

  • Chronic Ulcer of Lower Extremity
  • Wound
  • Botulinum Toxins, Type A
  • Blood Circulation

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Keywords

  • Botulinum Toxins, Type A
  • Wound
  • Chronic Ulcer of Lower Extremity
  • Blood Circulation
03

In context

Leg Ulcer

298 studies on the registry are indexed under Leg Ulcer; 43 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 241 interventional studies indexed under Leg Ulcer.

Browse Leg Ulcer studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 20 years old
  2. Patients who have a lower extremity wound among those who have been diagnosed with moderate or severe lower extremity ischemia
  3. Patients who are unable to perform additional procedures (angioplasty, etc.) by performing peripheral vascular examination and CT angiography
  4. Wound size ≥ 1x1cm2 to ≤ 3x3cm2
  5. Patients who can follow the clinical trial procedure well and abide by the visit schedule
  6. Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.

Exclusion criteria

Exclusion Criteria:

  1. Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
  2. Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, Rinco Those who have taken mycin antibiotics, etc.)
  3. Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
  4. Those who have received botulinum toxin preparations within 3 months before screening
  5. Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
  6. Cases in which blood flow to the lower extremities can be preserved by performing balloon angioplasty even if all three major blood vessels in the lower extremity are blocked
  7. Those who are currently taking steroids or immunosuppressants that affect wounds, or those who have taken them within one month of screening
  8. Those who have applied injection drugs or wound coverings that help improve wounds within 1 week of screening
  9. Women who are pregnant, lactating, planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods (women of childbearing age must be negative in the pregnancy test prior to injection).
  10. Those who are allergic or sensitive to botulinum toxin
  11. Those who have participated in another clinical trial within 30 days before screening or those who have not passed the half-life of the investigational product of the clinical trial that they participated in, whichever is longer.
  12. Those who are not suitable for this clinical trial under the judgment of other investigators
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Botulinum toxin A

    Single group(Botulinum toxin A) Open label

    Drug: Botulinum toxin A

Interventions

  • DrugBotulinum toxin A

    subcutaneous injection of Botulinum toxin A

06

What researchers measure

Primary outcomes

  1. Change in tcPO2(mmHg) measurement within the edge of 1cm Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)

    tcPO2 measurement

    Time frame: Baseline/7days after IP/14days after IP

Secondary outcomes

  1. Change in color-graded amount(using Thermal Imaging Camera) within Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)

    color-graded amount(using Thermal Imaging Camera)

    Time frame: Baseline/7days after IP/14days after IP

  2. Changes in wound quality and area in photographs at 7 days and 14 days after IP compared to baseline(Pre-administration IP)

    wound quality and area in photographs(Digital Camera)

    Time frame: Baseline/7days after IP/14days after IP

07

Study locations

1 of 1 sites recruiting
  • Yongin Severance Hospital
    Yongin-si, Gyeonggi-do 16995, Korea, Republic of
    • Hiisun Jeong, doctor · Contact
    • Hiisun Jeong, doctor · Principal investigator
    Recruiting
08

References and documents

Publications

  • Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5. PubMed 27997734 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 31, 2023

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06878482
Lead sponsor
Yonsei University
Responsible party
Hii Sun Jeong (Professor, Yonsei University) — Principal investigator
First posted
Mar 17, 2025
Start date
Apr 17, 2023
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Mar 17, 2025

Study contacts

Hiisun J, Dr
Contact
hsjeongps@yuhs.ac
823151899730
Hiisun J, Dr
principal investigator · Yonsei University College of Medicine, Yongin Severance

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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